French National Cohort of Patients With Rifampicin-Resistant Tuberculosis

NCT06565806 | Not Yet Recruiting

• 1 other identifier: APHP240748
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

A major obstacle in the fight against multidrug-resistant tuberculosis is its treatment. In 2021, only 60% of patients with MDR/RR tuberculosis who received treatment globally were successfully cured, while 12% succumbed to the disease and 10% experienced treatment failure. In France, a recent study by the National Reference Centre for Mycobacteria showed that while MDR/RR tuberculosis patients treated between 2006 and 2019 in the major reference centres in the Paris region achieved a favourable outcome in 68% of cases, 30% were lost. The main aim of this study is to enhance our understanding of the outcomes for patients suffering from tuberculosis due to rifampin-resistant bacilli, as well as the factors influencing these outcomes. Additionally, it aims to decrease the duration required to relay information to health authorities regarding the status of multidrug resistance and the outcomes of patients in France. A national longitudinal cohort will be develop to study multidrug-resistant tuberculosis in France. The cohort includes a historical retrospective part from 2006-2019 and a prospective part from 2020, with planned inclusions until 2029. The restrospective cohort includes 298 patients from 2006-2019 and 178 patients from the CNR mycobacteria national registry until 2024. As for the prospective cohort arm, a projected total of roughly 300 patients will be included over the period from 2020 to 2029. Non-identifying clinical data will be derived exclusively from patients medical records at three expert centres in the Paris region for the restrospective cohort and throughout France (national register) for the prospective cohorte. For the retropective cohorte each centers will transcribe pseudonymised clinical data into secure Excel files, while the prospective cohort will enter non-identifying data directly into the national register using a secure platform overseen by the CNR of Mycobactéria. Registry data will be extracted directly from the registry and merged with the retrospective database every 12 months by the coordinating investigator. Statistical analyses will include descriptive analyses of continuous and categorical variables, comparisons between subgroups using appropriate tests (Student's t, Mann-Whitney, Chi Square, Fisher), and logistic regressions to identify variables associated with treatment outcomes. P value \< 0.05 will be considered statistically significant

Conditions

Rifampicin-resistant Tuberculosis

Keywords

Tuberculosis; Rifampicin-resistant

Outcome Measures

Primary Outcomes (1)

• Outcome of tuberculosis treatment (WHO 2021 outcome definitons)

  Through out study time period (Till 2029)

Secondary Outcomes (1)

• Prognostic factors in the evolution of tuberculosis

  Through out study time period (Till 2029)

Study Arms (3)

Retrospective cohort 2006-2019

Retrospective cohort of the CNR national register of Mycobacteria from 2020 to end of May 2024

Prospective cohort of the CNR national register of Mycobacteria from June 2024 to the end of 2029

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient treated for MDR/RR tuberculosis in the major reference centres in the Paris region and throughout France (national register).

You may qualify if:

• Patient treated for MDR/RR tuberculosis
• In the major reference centres in the Paris region (CHU Pitié-Salpêtrière and Bichat \[Paris\], CH Bligny \[Briis-sous-Forges\]) for the retrospective part;
• Throughout France (national register) for the prospective part.

You may not qualify if:

• None

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Lorenzo GUGLIELMETTI, Dr

CONTACT

01 40 77 97 46; lorenzo.guglielmetti@aphp.fr

Jérome ROBERT, Pr

CONTACT

jerome.robert@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 22, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): September 1, 2032
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.